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GMP: ANSM publishes the French translation of Annex 1. How can you adapt your action plans?

GMP: ANSM publishes the French translation of Annex 1. How can you adapt your action plans? On 15 July, ANSM notified the publication online of the French translation of Annex 1 of the Good Manufacturing Practices (GMP) for medicinal products for human use. The European Commission had initially re-examined this chapter, dedicated to the specificities of the production of aseptic medicinal products, in order to standardise manufacturing practices on an international scale. Since its publication on EudraLex in August 2022, manufacturers have been complying with this original version, which has been in force since August 2023. The transposition of the revised Annex 1 of the European Good Manufacturing Process (GMP) is intended to remove any ambiguities about the enforceability of the text, since it effectively brings it into line with French law. For French manufacturers, this translated version should also clarify ambiguous wording and points in the original text. What impact will the revision of Annex 1 have on companies? How can it be implemented on production sites? What are the challenges of GMP compliance? Lugan Consulting has the answers. GMP: revision of Annex 1 on the manufacture of sterile medicinal products Appendix 1 lists the fundamental principles for the manufacture of sterile medicinal products. It was originally published in 1971 with the aim of providing an exhaustive manufacturing guide. It has already undergone several revisions. The most recent revision, in 2022, was initiated to take account of the impact of the Covid crisis, regulatory changes and the increasing use of new technologies for the manufacture of sterile medicinal products. A further update was needed to incorporate manufacturing strategies based on new technologies, to specify sterilisation methods and to take account of rapid analysis techniques. The new edition therefore includes 11 new sections, as well as a glossary for greater clarity. Scope of GMP Annex 1 ‘Sterile’ refers to medicines that are “uncontaminated by micro-organisms” (microbes, particles, bacteria, fungi, viruses, etc.). The absence of these elements is essential to guarantee the safety and efficacy of aseptic preparations, as their contamination could lead to serious or even fatal infections in patients. When we talk about the manufacture of sterile products, we are talking about products, different presentations, processes and technologies. These include Terminal sterilised medicinal products (ampoules and vials for injection, intravenous solutions, sterile eye drops and ointments, etc.) Medicinal products prepared in controlled atmosphere areas (vaccines, blood-derived medicinal products, medicinal products administered by intravenous or intrathecal injection, ophthalmic medicinal products, sterile topical medicinal products, etc.). Changes brought about by the update of GMP Annex 1 The introduction of the new Annex 1 has led to some major changes. The directives focus on preventing contamination, without minimising the detection or removal stages. The changes relate to 4 areas: Taking technology into account One of the recommendations (section 2.1) highlights the appropriate use of technology in aseptic production operations: restricted access barrier systems (RABS), isolators, single-use technologies, robotic systems, rapid or alternative methods, continuous monitoring systems, etc., in order to be able to rapidly detect any contamination of the environment or the product during the manufacturing process. For manufacturers, the introduction of technology can also be a solution to improve the reliability of operations or save time, such as the automation of candling, for example. However, the introduction of technology is the first step towards the future of aseptic manufacturing, with human presence reduced to a minimum (use of isotechnology). It is clear that the risks of contamination inherent in the latter can be reduced by introducing robotics, or even Artificial Intelligence. The big names, such as Sanofi, have already done this. However, the emphasis is on the fact that these technologies and automated monitoring systems need to be operated by staff who are trained and qualified to use them. In all cases, the use of the technologies must be documented in the CCS, another new feature of the update. Contamination Control Strategy (CCS) This is one of the major changes to be taken into account in this new version. CCS is a systematic, documented approach implemented as part of a policy to ensure and prevent the risks of contamination in the manufacture of sterile medicinal products. In practice, establishing this strategy involves drawing up technical and organisational documentation defining the means of control. It is then used as a reference for risk assessment. The key elements of an effective CCS are : Risk assessment: Identify potential sources of contamination in all aspects of manufacturing, including raw materials, equipment, personnel and production environments. Control measures: implement appropriate protocols to eliminate or minimise identified risks, such as disinfection, sterilisation and environmental monitoring. Monitoring: regularly observing the effectiveness of control measures and the presence of contaminants in environments and products. Review and update: regularly review and update the CCS to take account of changes in manufacturing processes, risks and scientific knowledge. The update recommends the implementation of a SCC, while stressing that manufacturers of sterile medicinal products must adapt it to their specific facilities and products. The SCC must be documented and applied by qualified personnel. They must have sufficient knowledge of sterilisation and microbiology at all levels of the organisation. Compliance with the CCS is now one of the inspection points monitored by the regulatory authorities. Quality Risk Management (QRM) Update 2024 does not introduce any new QRM requirements, but aims to achieve international harmonisation of processes, operations and limits. It therefore covers a wide range of subjects: the layout of cleanrooms, equipment and manufacturing methods, staff training, choice of clothing, cleaning and disinfection procedures, qualifications and monitoring systems, etc. Evidence of the implementation of risk management is characterised by : Appropriate design of plant, equipment and manufacturing processes. The creation of procedures adapted to the manufacturing activity specific to the type of product being manufactured. Setting up a monitoring system. QRM becomes a systematic and proactive approach, to be carried out throughout the sterile medicinal product manufacturing process (this is a link between the manufacture of sterile medicinal products and the

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Well-being at work: pharmaceutical industry managers as a remedy for employees?

WELL-BEING AT WORK: PHARMACEUTICAL INDUSTRY MANAGERS AS REMEDIES FOR EMPLOYEE ILLS Every year, Quality of Life at Work (QWL) week is a reminder that employees well-being is not a luxury, but an investment. Far from being a simple philanthropic issue, QWL is a proven competitive lever: more attractive companies, more committed employees, higher productivity. These arguments are leading to a proliferation of QWL initiatives, but the philosophy remains difficult to establish in the long term. This is particularly true of pharmaceutical manufacturers, who are facing specific challenges. The major changes currently taking place in the sector provide a relevant case study. The upheavals (relocation, restructuring, mergers and acquisitions, massive recruitment, etc.) mean that sustaining a QWL culture is no longer an option, but a necessity to ensure the success of the transformations. Against this backdrop of change, how can drug manufacturers safeguard the mental health of their teams and promote the fulfilment of their managers, who are the guarantors of performance? MANAGING TEAMS WITH CARE He is one of the company’s figureheads, the bearer of its colours and values. They are the ones who pass on the directives and practices endorsed by the entire management team. They ensure that these are applied in order to meet performance targets. The stakes involved in this pivotal role are often a source of pressure, fuelling stress that can have an impact on employees. Because of the manager’s position in the hierarchy, his active involvement in the decision-making process and his role as a transmitter of information, he is (increasingly!) seen as being responsible for the mental health of the people he supervises. In fact, studies into well-being at work regularly highlight employee/manager relations as the source of ill-being in the workplace. For example, the Malakoff Humanis “Absenteeism 2023” barometer shows rising figures: 50% of employees have been off work at least once during the year, the highest level since 2016. The proportion of long stoppages (more than 30 days) due to psychological problems has more than doubled (31% of companies are affected by this phenomenon). The study also shows that employees who have taken time off work for psychological reasons in the last 12 months blame their work environment and managerial practices. The reindustrialisation currently taking place in the region is having its share of repercussions for players in the sector. In this context, how can managers achieve their objectives while respecting the delicate balance between the company’s policy and the meaning that employees wish to give to their work, and above all while preserving their health? Lugan Consulting : coaching for managers – Crédit Photo : Laurent Besnehard – Le 7eme Studio The role of the manager in promoting well-being at work during a period of transition Above all, managers must approach their mission with sincerity. Authentic leadership is recognised as a lever for well-being. The QWL approach is therefore an incentive to remain oneself in one’s duties and to be in line with one’s values and deepest convictions (principle of coherence). Self-awareness (knowing one’s strengths, weaknesses, values, motivations, etc.) helps to ensure this posture. It naturally leads to an open and honest management style, based on trust and mutual respect. Authentic leaders delegate tasks and encourage autonomy. They are as focused on results as they are on the well-being of their employees. In addition to this approach, they can work with their teams in 4 different roles: The role of leader is one in which the manager is a team leader who stimulates autonomy and initiative-taking. Finally, as provided for in the collective agreement on well-being at work (2020), they must recognise and value their work. The role of organisational support consists, in practice, of maintaining a close operational relationship, but also of developing and supporting employees through individual and group coaching, training, the allocation of resources or the creation of ergonomic and pleasant workstations. He is a great believer in teamwork and cohesion. The role of emotional support. According to a 2023 Forrester study for Indeed, a manager’s empathy plays a major role in the well-being of employees, who mainly expect him or her to listen (62%) and provide support (49%) in difficult situations. Career development is also one of the issues they want to discuss (25%). To respond to these situations, the manager can rely on a compassionate stance, as well as active listening and openness to dialogue. They need to be able to help employees adapt to change. In practical terms, this means, for example, encouraging them to express their feelings. As a communicator, you need to be able to engage in a friendly exchange, based on active listening, and to pass on clear, transparent information, with no double-talk. Of course, this also means showing respect and confidence in their teams. This palette can be used as a tool to stimulate the 4 key objectives of QWL: Encouraging employee autonomy and empowerment; Develop clear and transparent communication; Encouraging trust, collaboration and teamwork; Implement stress and RPS prevention measures. Adapting your management style to the realities of the pharmaceutical sector The pharmaceutical sector presents unique challenges and opportunities for managing quality of life at work (QWL). To adapt to these realities, managers need to adopt an appropriate posture, taking into account the particularities of the field. Strict regulatory requirements: managers need to provide additional support (operational, organisational and emotional), foster open communication and create a climate of trust to help employees navigate a complex, legislated environment. Complex manufacturing processes: clear training, adequate resources and tools, and an environment where employees feel comfortable reporting problems and asking for help, are essential to ensure accuracy and quality. Operator safety: rigorous safety programmes, appropriate training and a safety culture where employees feel comfortable reporting hazards and asking for help are essential to protect workers. Teamwork and collaboration: fostering a cooperative environment where employees feel comfortable sharing ideas and working together. Effective communication and coordination between different teams is crucial to achieving common goals. Work-life balance: promoting practices such as teleworking, flexible

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Decarbonisation of pharmaceutical companies: how to get started?

Decarbonisation of pharmaceutical companies: how to get started? Whether you are a pharmaceutical manufacturer or a contract manufacturer, you should be aware that in October 2023, Leem introduced the signing of a collective industry pact. The consensus, entitled ‘Leem’s Decarbonisation Plan’, aims to bring the pharmaceutical industry into line with the objectives of the 2016 Paris Agreements. A study carried out by the union in 2022 estimates that the sector is responsible for 4.4% of global greenhouse gases (GHGs). French drug production alone generates a carbon footprint of 11.8 MtCO2e. In April 2023, the roadmap for the pharmaceutical industry, published by the Conseil National de l’Industrie (CNI), stated that 60% of companies in the sector had not yet undertaken a carbon footprint assessment. While there may be obstacles, there are many benefits to be gained from making the transition. Here’s an overview. The issues and challenges involved in decarbonising industry The IPCC’s alarmist reports are calling on nations to significantly accelerate the ecological transition processes already underway in their territories. By 2022, France has committed itself to a goal of decarbonising its industry. This ‘carbon neutral’ strategy targets 4 categories of challenges: Abandoning carbon, an environmental challenge Clearly, it is first and foremost the collective interest that is at stake. Reducing greenhouse gases (GHGs) is an altruistic act that marks a commitment to public health and the fight against the harmful effects of global warming. The energy transition, a regulatory challenge Faced with an accelerating climate emergency and the condemnation of the ECHR for inaction, public authorities at national and European level are setting their objectives within an increasingly strict legislative framework. Their commitment is set out in several founding texts. These include The Paris Agreement (2015) ; The Européan Alliance for Green Industry (2019) ; The AGEC act (2020) ; Climate and Résilience Act (2021) ; The National Decarbonisation Pact for french industry(2022). 💡 On 9 April 2024, the ECHR (European Court of Human Rights), in condemning Switzerland for its climate inaction, recognised the right of individuals to be protected by the State, against the harmful effects of climate change.al de Décarbonation de l’Industrie Française (2022). In France, for example, these requirements take the form of the CSRD directive (Corporate Sustainability Reporting Directive), which came into force on 1 January 2024. The directive requires large institutions (those with more than 500 employees and sales of €50 million and profits of €43 million for two consecutive years) to carry out an energy audit, which they must declare on ADEME’s Bilan GES portal, on pain of a fine of up to €50,000. A timetable sets out the 3 stages of implementation for each type of company. To date, the regulations are due to come into force for listed SMEs in 2026. It is easy to imagine that a change in the law will require all forms of company to comply by 2030.   Reducing emissions: an economic opportunity The saying is well known (and particularly relevant to the pharma sector): ‘Prevention is better than cure’. It also takes on its full meaning in the context of the ecological transition, where failure to anticipate has a negative impact. The costs of inaction on climate change are already measurable, and the figures that abound in reports point to clear trends: increase in the cost of insurance ; a multiplication of the cost of the additional resources needed to adapt to unforeseen disruptions; a growing impact on GDP. While the financing required for the decarbonisation process sometimes hinders the transition to action, it has a real return on investment. In the long term, inaction has a more severe impact on the company’s economy. The holistic approach of the ONE HEALT concept recognises the inextricable correlation between human, animal and environmental health. It highlights the cyclical effects of dependence on fossil fuels: the contamination of biotopes causes animal diseases which lead to human pathologies. This representation demonstrates the paradox of the pharmaceutical system, which, by polluting, not only increases what it exists to do, but also creates its own obstacles: the increase in extreme weather events, particularly in countries supplying raw materials (Asia, India, etc.) is one of the factors in the supply shortages affecting Europe. The damage caused to crops and production facilities, as well as the higher costs incurred in manufacturing and exporting, have repercussions at every stage of the drug supply chain. The ecological transition: a measure to ‘stay in the race’ Planning measures in favour of decarbonisation encourages approaches with a systemic effect: for example, one of the ideas put forward is to call on subcontractors who are themselves involved in a 0-carbon strategy. Over and above the moral commitment, decarbonising your business will prove essential to maintaining your competitiveness: not being decarbonised automatically risks taking you out of the loop, on the grounds that you are not contributing to green synergy. As well as raising the profile of the company, France sees decarbonisation as an argument for attractiveness. The government’s 0-carbon ambitions are combined with the ‘Choose France’ policy: being a pioneer in decarbonised industry and having, by 2025, eco-responsible industrial zones, a decarbonised mix and excellence in decarbonisation technologies should encourage foreign firms to set up here. Decarbonisation strategies of pharmaceutical manufacturers In a 2022 study, the Observatoire des Compétences Industries identifies 4 major sources of the pharmaceutical industry’s impact on the environment: the environmental footprint of packaging; the environmental footprint of logistics; the post-use management of products; the environmental impact of manufacturing, in relation to products quality and safety standards. The study also shows that responding to these issues is complicated by : the regulatory framework; the absence of technical or technological solutions; the complexity of value chains and of sourcing products locally (the fact that some French subsidiaries are part of a foreign group limits local R&D). The Leem industry agreement sets out 3 levers for action (the trajectories are calculated on the basis of companies that have not yet initiated their transition): decarbonisation of energy supply; decarbonising

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Data Integrity : 8 steps to becoming compliant

DATA INTEGRITY: 8 STEPS TO COMPLIANCE The pharmaceutical industry has to ensure a constant quest for quality in an ever-changing regulatory environment. To achieve this, the generation of electronic data has become an inevitable solution, and one that has been implemented in many organisations. Data servers, clouds… the practicality and time-saving benefits of digital technology are major advantages that promote functional quality systems. But like all developments, there is a corollary that must not be overlooked: data integrity. This has become a major security issue for pharmaceutical organisations. Find out below about the different phases you need to consider in order to achieve compliance and take the first steps in your data management policy. 1- KNOWING REGULATION Data integrity in the pharmaceutical industry is closely linked to Good Manufacturing Practice (GMP) and the GxP environment, encompassing Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP). These standards govern the processes and systems used in the production and distribution of medicines, guaranteeing their quality and safety. In France, compliance with these standards is mandatory under the Public Health Code, in particular articles L. 5111-1 and R. 5121-114, on pain of severe penalties and repercussions for the company’s reputation. As a reminder, you will find below a summary of the regulatory texts on data integrity in the pharmaceutical industry: Data Integrity and Compliance With Drug CGMP : Questions and Answers- Guidance for Industry MHRA’s ‘GXP’ Data Integrity Guidance and Definitions OECD’s Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity PIC/S’s Guide “Good practices for data management and  integrity in regulated GMP/GDP environments” Guide de bonnes pratiques de gestion des données et des enregistrements Annexe 11 des BPF : Guide des BPF pour les systèmes informatisés     What are the implications of non-compliance in terms of data integrity? Failure to comply with the regulatory texts on data integrity in the pharmaceutical industry obviously entails its share of sanctions: warnings, injunctions, withdrawal of marketing authorisations and criminal proceedings. It also has collateral consequences that I leave to you to assess: risks to public health ; economic repercussions damage to the company’s reputation. 2- MANAGING A PROJECT TEAM Compliance requires a collaborative approach, involving various stakeholders such as quality, IT and possibly legal teams. A project manager with data-integrity expertise is essential to structure the efforts and guarantee the effectiveness of the actions undertaken. A typical team dedicated to data integrity could be made up as follows: Quality manager: This professional is responsible for overseeing the entire compliance process and ensuring that standards and regulations are respected. He or she is the guarantor of data quality and works closely with other team members to coordinate actions and initiatives. IT Manager: responsible for selecting, implementing and maintaining the IT systems needed to manage and protect data. They must ensure that these systems comply with security and confidentiality standards. Regulatory expert: This professional has in-depth knowledge of the legislation in force in the pharmaceutical industry. They advise the team on regulatory requirements and ensure that all actions taken comply with these standards. Training Manager: Staff awareness and training are essential for the successful implementation of new processes and systems. The Training Manager is responsible for designing and delivering programmes tailored to each level of the organisation. Operational team members: In addition to the key players mentioned above, the project team may also include staff from different departments within the company, such as production, clinical procedures, research and development, etc. Their sector expertise and knowledge of the new processes and systems is essential for the success of the project. Their sector expertise and knowledge of specific business processes are invaluable in identifying the data integrity needs and challenges in their respective areas of activity. 3- UNDERSTANDING DATA FLOW An in-depth understanding of the flow of data is needed to identify points of vulnerability and implement appropriate controls. The dematerialisation of documents can facilitate this understanding by making data more accessible and more easily traceable, but it is important to know how it is organised and classified. The first steps to be taken are therefore to : Mapping data flows throughout the organisation to understand how data is generated, stored, transferred and used. Identifying critical points in the data flow where additional control measures may be required to ensure data integrity. Steps to compliance of data integrity 4- KNOW YOUR SYSTEMS La sécurité des données est un aspect critique de la gestion de l’intégrité des données. Cela comprend à la fois la sécurité physique des infrastructures et des supports de stockage, ainsi que la sécurité logique pour contrôler l’accès aux systèmes et aux données. Les mesures de sécurité doivent être robustes pour prévenir toute altération ou accès non autorisé aux données, et des plans de continuité d’activité doivent être établis pour garantir la disponibilité des données en cas d’incidents ou de sinistres. Votre plan doit ainsi prévoir d’effectuer un inventaire des systèmes informatiques et des processus associés. Il conviendra de s’assurer qu’ils sont conformes aux normes de qualité et de sécurité. Ensuite, il faudra identifier les lacunes potentielles dans les systèmes et proposer des solutions pour les corriger et améliorer l’intégrité des données. YOUR DATA INTEGRITY POLICY MADE SIMPLE LUGAN CONSULTING has established expertise in the field of Data Integrity. By delegating this task to us, you can ensure that your data is compliant with regulatory requirements. Contact us 5- ANALYSING CRITICALITY Some data is more critical than others and deserves special attention in terms of protection. An in-depth analysis of the criticality of data enables you to prioritise actions and concentrate efforts where they are most needed. For example, you could start by assessing the criticality of data in terms of its impact on the quality of pharmaceutical products and on patient safety. Then prioritise data governance efforts by focusing on the data that is most critical to the business. 6- EVALUATING SYSTEMS A systems audit is based on a number of principles, including the ALCOA +

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Pharmaceutical audit

INTERNAL AUDIT IN THE PHARMACEUTICAL INDUSTRY The pharmaceutical industry is faced with numerous risks related to non-compliance, product quality and inefficient process management. The consequences of these risks represent a real sword of Damocles for the managers of pharmaceutical manufacturing units. The constraints represented by the precautions to be taken to guard against them are omnipresent. As legislation evolves, manufacturers in the sector are under constant pressure to guarantee the safety and efficacy of their goods whilecomplying with the strict standards imposed by the regulatory authorities. Internal audit is a reliable tool in the fight against these risks. It enables a thorough assessment of processes, control systems and operational practices within pharmaceutical companies to avoid the damaging consequences of regulatory non-compliance, such as fines, product recalls or loss of reputation. ASSESSMENT POINTS TAKEN INTO ACCOUNT By identifying gaps and areas of non-compliance, the audit provides a valuable opportunity to initiate proactive corrective action. With this in mind, several aspects are closely examined: Production operations, including the weighing, manufacturing and packaging stages, are scrutinised to ensure their reliability. Stock management and distribution are assessed to maintain the integrity of products throughout their journey. Quality control, including physico-chemical and microbiological analyses, is scrutinised to ensure compliance with established standards. Technical aspects such as maintenance, purified water production systems and other utilities are also examined to ensure that they are working properly. PHARMACEUTICAL SECTOR AUDIT: SPECIFIC CONTROL POINTS In order to cover the specific aspects of the pharmaceutical quality system, the audits also cover : Pharmaceutical documentation (batch records, procedures, operating methods). Management of deviations and CAPA. The change management system (Change Control). Supplier quality system (approval, certification). Data integrity. Staff training. Maintenance (preventive, calibration and calibration). BENEFITS OF INTERNAL AUDIT Regulatory Compliance The internal audit ensures that the company’s activities comply with current standards and regulations, thereby reducing the risk of non-compliance. It also avoids the risk of receiving an ANSM injunction. Continuous improvement By identifying shortcomings and proposing recommendations, internal audit helps to improve internal processes and enhance operational efficiency. Risk Management By assessing potential risks and implementing preventive measures, internal audit helps to anticipate and manage the risks associated with pharmaceutical activities. By integrating an internal audit programme, you can ensure quality, compliance and overall performance throughout the organisation. By implementing regular controls, you can identify opportunities for improvement, build stakeholder confidence and ensure the sustainability of your business in a highly regulated environment. Investing in dedicated internal control resources, training your staff in best practice and implementing a continuous improvement process will position you as a reliable player in the pharmaceutical sector. GET AN OUTSIDE VIEW OF YOUR ACTIVITIES How do you rate your level of compliance? Are you confident about your next regulatory inspections? Contact LUGAN CONSULTING for a more detailed discussion of your needs and your sector. (contact@luganconsulting.com) Contact us Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Latest posts Data Integrity : 8 steps to becoming compliant Pharmaceutical audit Team building : secret of success ANSM injunction : how to react ? The drug manufacturing process : from research to market launch

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Team building : secret of success

Team cohesion: the secret of success In today’s business world, a company’s success depends to a large extent on the ability of its teams to work together harmoniously and effectively. Team cohesion is essential to achieving objectives and stimulating innovation. Yet building and maintaining this unity is not always an easy task. In this article, we explore the key elements that promotecollective understanding, highlighting the importance of roles and responsibilities, the different phases of team building, and the imperative of having a clear vision and mission. Building a Team by Following the Steps To build a solid, high-performance team, it is important to understand the different stages in a group’s development. Bruce Wayne Tuckman, American psychologist and father of team-building , formalised the eponymous diagram which describes the four key stages through which teams pass: Step 1 : Forming At the beginning, team members get to know each other and try to understand their respective roles. This is a phase where expectations are often unclear, and where it is important for the leader to guide and clarify objectives and processes. Step 2 : Storming As members begin to work together, conflicts and differences of opinion may arise, particularly about how to achieve objectives. This is a necessary stage where members learn to negotiate and resolve conflicts constructively. Step 3 : Norming Once the initial tensions have been overcome, the team begins to find its rhythm and establish common working standards. Communication improves and members learn to collaborate effectively. This is a stage where the team begins to structure itself, with rules standardised through a common working framework. Step 4 : Performing In this final phase, the team is working to its full potential. The members are autonomous, motivated and work together coherently to achieve the objectives set. Cooperation is efficient. Tuckman’s principle (Click for zooming) DEFINE THE VISION AND MISSION A clear vision and mission are the glue that keeps a team together and motivated. The vision defines the team’s long-term goal, while the mission sets out its immediate purpose and core values. When all team members share and believe in this vision and mission, they are more likely to work together harmoniously and overcome obstacles with determination. GETTING TO KNOW EACH OTHER BETTER TO WORK BETTER TOGETHER This training course from our catalogue is dedicated to strengthening team cohesion by working on communication. Contact us Unite the group by clarifying roles and responsibilities ​ Each team member brings unique expertise and specific skills. You will optimise the group’s performance by clearly defining each person’s roles and responsibilities. This strategy not only avoids overlap and conflict, but also ensures that each individual’s potential is fully exploited. By assigning clear missions, team members understand what is expected of them and can concentrate on accomplishing their specific tasks. The result is a feeling of trust and mutual respect between employees, because everyone knows that they can count on the others to fulfil their commitments. The Belbin model (Dr Meredith Belbin) establishes an inventory of roles according to 3 categories: Thinking roles (Designer, Taker, Expert) Action roles (Organiser, Promoter, Perfecter) Relationship roles (Coordinator, Supporter, Promoter) Each individual has a specific role within the team. By identifying and defining each person’s role, you can better understand your strengths and work together more effectively. Belbin’s model Team cohesion is an essential element of organisational success. By clearly defining roles and responsibilities, successfully navigating the Tuckman model of team building, and cultivating a shared vision and mission, teams can not only achieve their goals, but also thrive and innovate in a collaborative and motivating work environment. TEAM-BUILDING WORKSHOPS IN YOUR OFFICES! LUGAN CONSULTING can come to your company and organise fun, interactive team-building workshops. Book a session now. Contact us Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Last posts Data Integrity : 8 steps to becoming compliant Pharmaceutical audit Team building : secret of success ANSM injunction : how to react ? The drug manufacturing process : from research to market launch

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ANSM injunction : how to react ?

ANSM injunction: how to react? In France, ANSM (Agence Nationale de Sécurité du Médicament)  is the authority responsible for protecting public health. If a any risk would threats this one, the potential harm caused by a failure in the drug manufacturing chain, the manufacturer concerned receives an ANSM injunction. These must be treated seriously, as they can have significant repercussions for a pharmaceutical company. In addition to the risks to reputation and consumer confidence, failure to comply with regulatory requirements can lead to severe legal consequences, including fines and suspension of marketing authorisation. It is therefore imperative for companies to act swiftly to safeguard the quality and compliance of their products. This article guides you through the essential steps you need to take to respond to an animal health decision and ensure your company’s compliance with regulatory standards. Reply to the ANSM advance letter On receipt of the preliminary inspection report (or a letter prior to the ANSM injunction), the offending company enters what is known as the contradictory period. During this phase, it is essential to manage communication with the inspection body effectively, responding fully and within the time limits set. The response must be carefully drafted, firstly describing the precautionary measures put in place prior to compliance. Secondly, the operator must provide precise information and present a clear action plan to remedy the shortcomings identified. This letter also provides an opportunity to express any objections or comments on the health decision.The ANSM then assesses the resources and protective measures taken to ensure that the corrective measures are appropriate and effective. If the solutions are sufficient, the injunction will not be adopted. If not, the company will be notified. Responding to the injunction by building an action plan The probationary period mentioned in the injunction takes effect on the day of notification of receipt of the injunction. At the same time, the document is also published on the national regulator’s website for public access. During this phase, it is essential to set up milestones to monitor progress towards compliance. For example, it is advisable to : conduct an internal audit; identifying gaps improving procedures applying best practice; train staff; strengthen quality control strengthen validation and qualification introduce traceability; implement a monitoring and continuous improvement procedure… The various possible outcomes of an injunction must be taken into account, whether they be regularisations, maintenance after the last deadline, cancellations or partial extensions. Once the action plan has been implemented, the operator must provide proof of compliance during a new inspection. This will determine how the rest of the procedure will proceed. LUGAN CONSULTING: EXPERTISE IN PHARMA PROCESSES Call on our experience to help you set up an action plan to comply with an ANSM injunction. Contact us Impact of an ANSM injunction Once the probationary inspection has been completed, the regulator may : Either declare that compliance has been fully achieved, in which case the injunction will be lifted. Or decide that insufficient action has been taken, and issue a formal notice. Failure to comply with a complete procedure leads to two types of penalty: Financial penalties They are applied in cases where the manufacturer fails to fulfil one of its obligations or repeats a fault. It should also be noted that they can be combined with any penalty payment, but not with criminal proceedings. Criminal penalties In the event of non-compliance with a public health order or where human health is directly endangered, the regulatory authority may assert non-compliance with the public health code and decide to take the company to criminal court. Faced with injunctions from the ANSM, responsiveness and vigilance are essential for pharmaceutical companies. By working closely with the regulatory authorities, companies can maintain the quality and compliance of their products, while preserving consumer confidence and ensuring public safety. By adopting a proactive and transparent approach, companies can turn regulatory challenges into opportunities for continuous improvement and sustainable growth. FACING AN ANSM INJUNCTION? Contact our services. LUGAN CONSULTING offers a comprehensive range of consulting, auditing, coaching and training services dedicated to the pharmaceutical industry. Contact us Source : ANSM : Décisions (Lignes directrices relatives aux suites d’inspection) Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Autres infos Decarbonisation of pharmaceutical companies: how to get started? Décarbonation des entreprises pharmaceutiques : quelles pistes suivre pour l’initier ? Data Integrity : 8 steps to becoming compliant Intégrité des données : 8 étapes pour se mettre en conformité Pharmaceutical audit L’audit interne dans l’industrie pharmaceutique Team building : secret of success Cohésion d’équipe : le secret du succès ANSM injunction : how to react ? Injonction ANSM : comment y répondre

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The drug manufacturing process : from research to market launch

THE DRUG MANUFACTURING PROCESS : FROM RESEARCH TO MARKET LAUNCH The pharmaceutical industry is a complex field in which the research, development and marketing of a medicine follow a rigorous path. There are many stages in this circuit , all designed to ensure the efficacy, safety and quality of the products that reach patients. Let’s take a look at how the drug manufacturing works, from conception to availability on pharmacy shelves. Research and testing: 8 to 10 years The first stage in the development of a drug is pharmaceutical research. It often begins with the identification of unmet medical needs in the treatment of a specific disease. Once these needs have been clearly defined, scientists embark on a relentless quest to discover new molecules or develop innovative treatments. Patent registration The research process can take years, and each discovery goes through rigorous stages. First, a patent is filed to protect the new compound or technology developed. Next, preclinical trials are carried out to assess the drug’s toxicity, pharmacokinetics and potential efficacy in animal models. Clinical tests Once pre-clinical results are satisfactory, drug candidates are selected, followed by clinical trials. These tests on humans are conducted in several phases to assess the efficacy and safety of the drug in patients. This stage can take several years and involve thousands of participants. Approvals and production start-up: 1 to 3 years Once the clinical trials have been completed and the results analysed, the drug manufacturer must obtain regulatory authorisation to market the product. The Marketing Authorisation Application (MAA) is submitted to the relevant authorities, such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA). Validation of the marketing authorisation dossier requires a full presentation of research data, the results of clinical trials, and information on the manufacture and quality control of the drug. Transparency is essential at this stage, with open communication on the risks and benefits of the drug. Once marketing authorisation has been obtained, the price and reimbursement of the drug are set, often in collaboration with public health bodies and insurance companies. The industrial manufacture of the drug then begins, following Good Manufacturing Practices (GMP) to guarantee its quality, safety and efficacy throughout the production process. Life of Medicines: 20 years and over A medicine begins its active life as soon as it is made available on the market. For approximately 20 years, the patent holder has exclusive marketing rights. It is only once this period has elapsed that the property right expires. From then on, other manufacturers can produce generic versions of the drug. The end of the patent often marks the start of a period of increased competition and lower prices, which can benefit patients by making treatments more accessible. However, generic manufacturers must also comply with strict standards, while offering effective alternatives to branded products. This complex journey requires an unwavering commitment to science, regulation and, above all, the health and well-being of patients. Every step of the way must ensure that the medicines that reach their hands are safe, effective and of high quality. CHALLENGES OF INDUSTRIALISATION France is experiencing a boom in pharmaceutical industrialisation. The challenges facing companies in this sector are numerous. LUGAN CONSULTING can help you manage change and implement good manufacturing practices, so that you have every advantage on your side. Contact us Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Latest posts Data Integrity : 8 steps to becoming compliant Pharmaceutical audit Team building : secret of success ANSM injunction : how to react ? The drug manufacturing process : from research to market launch